H., Tanioka Y., Miyamoto A., Tsuji M., Asayama T., Shiraishi S., Yuki M., Kotaka A., Makiyama M., Shimokawa T., Shimose S., Masuda T., Yamaguchi Y., Komatsu H., Saeki Y., Emi H. E., Oki Y., Maehara Cancer, Kyushu Study Group of Clinical Supplementary Material for: Prophylactic Effect of Dexamethasone on Regorafenib-Related Fatigue and/or Malaise: A Randomized, Placebo-Controlled, Double-Blind Clinical Study in Patients with Unresectable Metastatic Colorectal Cancer (KSCC1402/HGCSG1402) <b><i>Background:</i></b> Regorafenib is an oral multikinase inhibitor with a proven survival benefit for metastatic colorectal cancer patients. The KSCC1402/HGCSG1402 study investigated the prophylactic effect of oral dexamethasone (DEX) on regorafenib-related fatigue and/or malaise. <b><i>Patients and Methods:</i></b> Patients who progressed after standard chemotherapy were randomized 1: 1 to a DEX group (2 mg/day; days 1–28) with regorafenib or a placebo group with regorafenib. The primary endpoint was the incidence of fatigue and/or malaise, based on version 4.0 of the National Cancer Institute’s CTCAE (Common Terminology Criteria for Adverse Events). One of the secondary endpoints was the in­cidence of fatigue and/or malaise based on the CTCAE assessed by patient-reported outcome (PRO). <b><i>Results:</i></b> The incidence of any grade of fatigue and/or malaise assessed by the investigators was 58.8% in the DEX group and 61.1% in the placebo group (<i>p</i> = 0.8101), and that assessed by PRO was 47.2 and 58.3%, respectively (<i>p</i> = 0.3450). The incidence of grade ≥2 fatigue and/or malaise, as assessed by the investigators, was 19.4% for the DEX group and 38.9% for the placebo group (<i>p</i> = 0.0695), and that assessed by PRO was 27.8 and 52.8%, respectively (<i>p</i> = 0.0306). <b><i>Conclusion:</i></b> Our results suggest that prophylactic oral DEX is clinically effective in improving regorafenib-related fatigue and/or malaise. Colorectal cancer;Regorafenib;Fatigue;Malaise;Dexamethasone 2018-03-07
    https://karger.figshare.com/articles/dataset/Supplementary_Material_for_Prophylactic_Effect_of_Dexamethasone_on_Regorafenib-Related_Fatigue_and_or_Malaise_A_Randomized_Placebo-Controlled_Double-Blind_Clinical_Study_in_Patients_with_Unresectable_Metastatic_Colorectal_Cancer_KSCC1402_HGCSG1402_/5955847
10.6084/m9.figshare.5955847.v1